Chronic Kidney DiseasePhase 305DNCT02492620
Ferric Citrate for the Transition From CKD Stage 4/5 to CKD Stage 5D
A Phase 3 study testing Ferric Citrate in people with Chronic Kidney Disease and Hyperphosphatemia, run by Denver Nephrologists, P.C. at 1 site in United States.
Trial summary
It is the investigators hypothesis that participants treated with Ferric Citrate (FC) during the non-dialysis CKD stage (4/5) with sufficient duration prior to initiating RRT, will result in improved biochemical control of anemia (Hb, TSAT) and mineral metabolism (P, FGF23) and furthermore, will result in a reduced… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease, Hyperphosphatemia, Iron Deficiency Anemia
- What is being tested?
- Ferric Citrate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to Nov 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years at screening visit
- Serum phosphate > or equal to 3.0 mg/dL obtained at screening
- CKD with eGFR < or equal to 20 mL/min obtained at screening*
- Hemoglobin (Hgb) >8.0 g/dL obtained at screening
- TSAT <55% obtained at screening
- Females of child bearing potential with negative serum pregnancy test obtained at screening
- Willing and able to give written informed consent
- Anticipated to have > or equal to 8 weeks prior to need for initiating RRT in the opinion of the investigator
Who cannot join
- Liver enzymes (ALT/AST) >X3 times upper limit of normal at screening
- Use of IV iron, blood transfusions or ESA agents within 2 weeks prior to the screening visit and prior to the Day 1 visit.
- Evidence of acute kidney injury (i.e., no CKD) or planned need for RRT within 12 weeks of screening
- Scheduled kidney transplant within 24 weeks of screening
- Contra-indication to ferric citrate: iron overload syndrome, allergic reaction or known intolerance to ferric citrate
- Clinically significant medical condition felt to interfere with tolerance of oral medication
Show all 13Show fewer
- Life expectancy < 6 months or confirmed conviction that subject does NOT want to initiate RRT despite a decline in kidney function
- Active drug or alcohol dependence or abuse (excluding tobacco use or marijuana use) within the 12 months prior to screening (in the opinion of the PI)
- Psychiatric disorder that interferes with the subject's ability to comply with the study protocol in the opinion of the PI
- Any other medical condition that, in the opinion of the PI, renders the subject unable to or unlikely to complete the trial or that would interfere with optimal participation in the trial or produce significant risk to the subject
- Inability to cooperate with study personnel or study procedures
- Females who are pregnant or breastfeeding
- Receiving or has received any investigational drug with in the past 30 days prior to the Day 1 visit
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Two-Arm, Open-Label, Standard of Care Control Evaluation of Ferric Citrate for the Transition From Chronic Kidney Disease Stage 4/5 to Chronic Kidney Stage 5D
It is the investigators hypothesis that participants treated with Ferric Citrate (FC) during the non-dialysis CKD stage (4/5) with sufficient duration prior to initiating RRT, will result in improved biochemical control of anemia (Hb, TSAT) and mineral metabolism (P, FGF23) and furthermore, will result in a reduced need for ESA and intravenous iron. The investigators further hypothesize that effective treatment of anemia and mineral metabolism with FC in the pre-dialysis and transition period will result in improved physical functioning, reduced hospitalization and reduced total cost of care when compared to participants receiving contemporaneously provided standard of care therapy.
Read the detailed description
This is an up to 50 week, phase 3, clinical trial in patients with estimated glomerular filtration rate (eGFR) ≤ 20 ml/min/1.73m2. It will be comprised of an up to 36-week non-dialysis period (NDP), or until such time as subjects require renal replacement therapy (RRT) with dialysis when they will immediately roll into a 12-week dialysis period (DP). The study will consist of up to 16 clinic visits over a maximum period of 50 weeks. There will be a screening period of up to 14 days after which subjects will be randomized into the NDP in a 2:1 ratio to receive either FC (n=150) or SOC (n=75). Each eligible participant will be randomized to either fixed dose open-label ferric citrate (FC) or standard of care (SOC) treatment. Participants randomized to SOC will receive care directed by their primary nephrologist throughout the study duration with the only restriction being that they cannot receive treatment with FC during the NDP or DP. Participants randomized to FC will receive it throughout the study duration.
220 participants were screened to randomize 200 subjects 2:1 (FC:SOC) into the NDP. It is anticipated that 35-45% of participants will reach the dialysis period (DP) during the 36 week follow up. Participants who initiate RRT with dialysis will enter the Dialysis Period (DP) during which those participants previously assigned to ferric citrate will continue to receive open-label ferric citrate and those previously assigned to SOC will receive open-label, non-FC phosphate binders at the discretion of their treating physician. During this period all participants will be treated to standard of care guidelines which suggest that if serum phosphate is above the upper limit of normal (4.5 mg/dL), it should be reduced. During the DP, dose of P binders, use of ESA, intravenous iron and blood transfusions will be at the discretion of the primary treating nephrologist. Participants assigned to the SOC treatment arm may not receive FC at any point during the study.
Only participants that begin permanent RRT with dialysis will be eligible to enter the 12 week DP. Participants that do not begin RRT after 9 months participation in the NDP will be deemed to have reach the end of study and have end of study procedures performed.
- Being tested
- Ferric Citrate
- Keywords
- ferric citrate, phosphate, kidney
- Medical subject headings
- Renal Insufficiency, Chronic, Hyperphosphatemia, Anemia, Iron-Deficiency, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferric CitrateDrug
Also called Auryxia
Auryxia (ferric citrate) is a non calcium based phosphate binder indicated for the control of serum phosphorus levels in patients with chronic kidney disease on dialysis
| Study group | Role | What they receive |
|---|---|---|
| Ferric Citrate | Active comparator | Ferric citrate (FC) will be supplied as tablets containing 210mg of ferric iron (as 1g ferric citrate) to those subjects randomized to FC. These participants will be initiated on study drug with a fixed dose of FC beginning with 2 tablet per meal. Receives: Drug: Ferric Citrate |
| Standard of Care (SOC) | No intervention | Participants may receive open-label, non-FC phosphate binders at the discretion of their treating physician. During the Dialysis Period, dose of phosphate binders, use of ESA, intravenous iron and blood transfusions will be at the discretion of the primary treating nephrologist. Participants assigned to the SOC treatment arm may not receive FC at any point during the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum phosphate value prior to starting renal replacement therapy
Measured: baseline
Secondary outcomes (3)
Serum hemoglobin prior to starting renal replacement therapy
Measured: baseline
Serum transferrin saturation prior to starting renal replacement therapy
Measured: baseline
Serum fibroblast growth factor 23 prior to starting renal replacement therapy
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2015 (estimated)
- Study startMar 2015
- Primary completionNov 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Denver Nephrologists, P.C.
- Sponsor type
- University, hospital or other
- Collaborators
- Keryx Biopharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Geoffrey A Block, MD, Principal investigator, Denver Nephrologists, P.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02492620
- Sponsor's protocol ID
- 05D
- Acronym
- 05D
- Status last verified
- Jul 2018
- First submitted
- 30 Jun 2015
- Last updated
- 1 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Natale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4.
PubMed 40576086
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-Arm, Open-Label, Standard of Care Control Evaluation of Ferric Citrate for the Transition From Chronic Kidney Disease Stage 4/5 to Chronic Kidney Stage 5D
- ClinicalTrials.gov ID
- NCT02492620
- Acronym / sponsor ID
- 05D / 05D
- Keywords
- ferric citrate, phosphate, kidney
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Denver Nephrologists, P.C.University, hospital or other
- Collaborators
- Keryx Biopharmaceuticals
- Study start
- Mar 2015
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 8 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It is the investigators hypothesis that participants treated with Ferric Citrate (FC) during the non-dialysis CKD stage (4/5) with sufficient duration prior to initiating RRT, will result in improved biochemical control of anemia (Hb, TSAT) and mineral metabolism (P, FGF23) and furthermore, will result in a reduced need for ESA and intravenous iron. The investigators further hypothesize that effective treatment of anemia and mineral metabolism with FC in the pre-dialysis and transition period will result in improved physical functioning, reduced hospitalization and reduced total cost of care when compared to participants receiving contemporaneously provided standard of care therapy.
Detailed description
This is an up to 50 week, phase 3, clinical trial in patients with estimated glomerular filtration rate (eGFR) ≤ 20 ml/min/1.73m2. It will be comprised of an up to 36-week non-dialysis period (NDP), or until such time as subjects require renal replacement therapy (RRT) with dialysis when they will immediately roll into a 12-week dialysis period (DP). The study will consist of up to 16 clinic visits over a maximum period of 50 weeks. There will be a screening period of up to 14 days after which subjects will be randomized into the NDP in a 2:1 ratio to receive either FC (n=150) or SOC (n=75). Each eligible participant will be randomized to either fixed dose open-label ferric citrate (FC) or standard of care (SOC) treatment. Participants randomized to SOC will receive care directed by their primary nephrologist throughout the study duration with the only restriction being that they cannot receive treatment with FC during the NDP or DP. Participants randomized to FC will receive it throughout the study duration.
220 participants were screened to randomize 200 subjects 2:1 (FC:SOC) into the NDP. It is anticipated that 35-45% of participants will reach the dialysis period (DP) during the 36 week follow up. Participants who initiate RRT with dialysis will enter the Dialysis Period (DP) during which those participants previously assigned to ferric citrate will continue to receive open-label ferric citrate and those previously assigned to SOC will receive open-label, non-FC phosphate binders at the discretion of their treating physician. During this period all participants will be treated to standard of care guidelines which suggest that if serum phosphate is above the upper limit of normal (4.5 mg/dL), it should be reduced. During the DP, dose of P binders, use of ESA, intravenous iron and blood transfusions will be at the discretion of the primary treating nephrologist. Participants assigned to the SOC treatment arm may not receive FC at any point during the study.
Only participants that begin permanent RRT with dialysis will be eligible to enter the 12 week DP. Participants that do not begin RRT after 9 months participation in the NDP will be deemed to have reach the end of study and have end of study procedures performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ferric Citrate | Active comparator | Drug: Ferric CitrateFerric citrate (FC) will be supplied as tablets containing 210mg of ferric iron (as 1g ferric citrate) to those subjects randomized to FC. These participants will be initiated on study drug with a fixed dose of FC beginning with 2 tablet per meal. |
| Standard of Care (SOC) | No intervention | –Participants may receive open-label, non-FC phosphate binders at the discretion of their treating physician. During the Dialysis Period, dose of phosphate binders, use of ESA, intravenous iron and blood transfusions will be at the discretion of the primary treating nephrologist. Participants assigned to the SOC treatment arm may not receive FC at any point during the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age >18 years at screening visit
- Serum phosphate > or equal to 3.0 mg/dL obtained at screening
- CKD with eGFR < or equal to 20 mL/min obtained at screening*
- Hemoglobin (Hgb) >8.0 g/dL obtained at screening
- TSAT <55% obtained at screening
Key exclusion criteria (13 listed)
- Liver enzymes (ALT/AST) >X3 times upper limit of normal at screening
- Use of IV iron, blood transfusions or ESA agents within 2 weeks prior to the screening visit and prior to the Day 1 visit.
- Evidence of acute kidney injury (i.e., no CKD) or planned need for RRT within 12 weeks of screening
- Scheduled kidney transplant within 24 weeks of screening
- Contra-indication to ferric citrate: iron overload syndrome, allergic reaction or known intolerance to ferric citrate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ferric CitrateAlso: AuryxiaAuryxia (ferric citrate) is a non calcium based phosphate binder indicated for the control of serum phosphorus levels in patients with chronic kidney disease on dialysis | Drug | Ferric Citrate |
Primary outcome
Serum phosphate value prior to starting renal replacement therapy
Time frame: baseline
3 secondary outcomes
Serum hemoglobin prior to starting renal replacement therapy
Time frame: baseline
Serum transferrin saturation prior to starting renal replacement therapy
Time frame: baseline
Serum fibroblast growth factor 23 prior to starting renal replacement therapy
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2018.
- Derived from this study: PubMed 40576086Natale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Geoffrey A Block, MD principal investigator
Denver Nephrologists, P.C.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ferric Citrate in people with Chronic Kidney Disease and Hyperphosphatemia, run by Denver Nephrologists, P.C. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum phosphate value prior to starting renal replacement therapy (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02492620, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2018.